Disclosure of Invention
In order to solve the problems, the invention provides a conveying device of an intravascular distal protector, which can intercept thrombus with the diameter of more than 0.05mm in cerebral vein interventional molding and ensure that broken thrombus can not cause drifting or re-embolism.
A delivery device for a vascular distal protector, comprising:
a vascular distal protector;
the inner cavity of the outer sheath tube is divided into a first cavity and a second cavity which are adjacent to each other by the interlayer; the first lumen accommodates a collapsed distal vascular protector;
a push assembly comprising: a push rod and a protector guidewire connected to the distal end of the push rod; the distal end of the protector guide wire is connected with the proximal end of the vascular distal protector; the pushing component is used for pushing the vascular distal protector accommodated in the first cavity of the outer sheath tube out of the distal end of the outer sheath tube.
In the above-mentioned delivery device for a vascular distal protector, as a preferred embodiment, a side hole is provided in a side wall of the sheath tube, which is used for forming the second lumen and is close to the proximal end of the sheath tube.
In the above-mentioned delivery device for a vascular distal protector, as a preferred embodiment, the delivery device further includes a guide wire for guiding the outer sheath to a predetermined position when the vascular distal protector is delivered, a portion of the guide wire penetrating the second lumen and a proximal end of the guide wire protruding from the side hole.
In the above-mentioned delivery device for a vascular distal protector, as a preferred embodiment, the delivery device further comprises an extension guide wire, and the protector guide wire is connected to the push rod through the extension guide wire; preferably, the extension guide wire is connected with the protector guide wire in a threaded manner, and the push rod is connected with the extension guide wire in a threaded manner.
In the above-mentioned delivery device for a vascular distal protector, as a preferred embodiment, in the open state, the vascular distal protector is of an elastic basket-like structure with an opening towards the proximal end of the delivery device; preferably, the vascular distal protector comprises; the metal basket comprises a metal basket body and a high polymer film layer coated on the metal basket body, wherein holes are formed in the high polymer film layer; more preferably, the mesh diameter on the metal basket body is 100-5000 μm, preferably 200-2000 μm, further preferably 300-1000 μm.
In the above-described delivery device for a vascular distal end protector, as a preferred embodiment, in the open state, the metallic basket body includes: the device comprises a distal part, a middle part and a proximal part which are sequentially connected, wherein the distal part is hemispherical or semi-elliptical, the middle part is cylindrical, and the proximal part is a cylinder with an inclined opening; further preferably, a portion of the inclined opening closest to the proximal end of the delivery device is connected to the distal end of the protector guidewire, and the plane of the inclined opening forms an obtuse angle with the protector guidewire; preferably, the diameter of the middle section is the same as the diameter of the proximal section.
In the above-mentioned delivery device for a vascular distal end protector, as a preferred embodiment, the thickness of the polymer film layer is 0.1 to 200 μm, preferably, the average thickness of the polymer film layer coated on the inner surface of the metal basket body is 0.1 to 50 μm, and the average thickness of the polymer film layer coated on the outer surface of the metal basket body is 0.1 to 50 μm; more preferably, the whole distal end of the metal basket body is coated with the polymer film layer; further preferably, the middle section of the metal basket body is coated with the polymer film layer; more preferably, the polymer film layer is coated on the part of the middle section connected with the far end part of the metal basket body, and the area of the middle section of the part coated with the polymer film layer accounts for 30-50% of the area of the whole middle section; more preferably, the edge portion of the polymer film layer has a streamlined smooth transition region.
In the above-mentioned vascular distal protector delivery device, as a preferred embodiment, 1 to 2000 holes are uniformly distributed on the polymer film layer per square millimeter; preferably, the diameter of the holes is 30-200 μm, preferably 60-120 μm; preferably, a plurality of developing marks are arranged on the metal basket body.
In the above-mentioned vascular distal protector delivery device, as a preferred embodiment, the polymer film layer is made of polyurethane or polytetrafluoroethylene; the raw material of the polymer film layer is polyurethane preferably; more preferably, the polyurethane has an average molecular weight of 100000 ～ 1000000g/mol; more preferably, the polyurethane is preferably any one of a teccoflex series aliphatic polyurethane and a Pellethane2363 series 80AE aromatic polyurethane.
In the above-mentioned vascular distal protector delivery device, as a preferred embodiment, the metal basket body is woven from a single or multiple nickel-titanium alloy wires; or is formed by cutting nickel-titanium alloy, medical stainless steel or cobalt-chromium alloy metal pipe by laser; or is formed by 3D printing of metal alloy powder.
The film covering method of the vascular distal protector sequentially comprises the following steps:
step one, dissolving the raw materials of the polymer film in an organic solvent and adding a pore-forming agent to form a pre-coating liquid;
step two, degassing the precoating liquid to obtain a coating liquid;
step three, dip-coating the coating liquid on the metal basket body by adopting a dip-coating method, wherein the metal basket body is subjected to air-drying treatment after dip-coating each time, and the metal basket body with a coating is obtained after dip-coating and air-drying treatment for a plurality of times;
And fourthly, flushing the metal basket body with the coating for multiple times by adopting a reagent until the pore-forming agent is completely washed to form the holes, and then drying to obtain the elastic protective basket.
Compared with the prior art, the invention has the following technical benefits:
1. the design of the metal basket body can be well attached to the wall of a blood vessel, has small stimulation to the blood vessel, can be contracted into a smaller outline, prevents the wall of the blood vessel from being damaged in the operation process, can collect thrombus at the maximum area, ensures stable blood flow, can effectively support and protect the blood vessel, is more comfortable in release, does not tear or scratch the wall of the blood vessel, and has larger contact area with the wall of the blood vessel after the far-end protector of the blood vessel is opened, thus being not easy to shift due to the impact of blood flow and thrombus.
2. The metal basket body is covered with the membrane and the dense holes are formed in the membrane, so that not only can the efficient collection of thrombus be realized, but also the distal blood flow can be ensured.
4. The vascular distal protector can intercept thrombus with the diameter of more than 0.05mm when being used in cerebral vein interventional molding, ensures that the broken thrombus cannot drift or re-embolism, and can be also used for carotid interventional molding and renal artery interventional molding.
5. By adopting the conveying device of the vascular distal protector, the problems of incarceration and the like of the guide wire and the protector in the process of conveying the protector are avoided, namely the prior common guide wire with the guide function is not wound together with the protector, thereby bringing convenience to an operator and realizing the rapid conveying and recycling of the protector.
6. The design of the extension guide wire in the device can enable an operator to freely switch the length of the guide wire in operation according to the needs.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the present invention more apparent, embodiments of the present invention will be described in further detail below with reference to the accompanying drawings. It should be understood that the detailed description and specific examples, while indicating and illustrating the invention, are not intended to limit the invention.
In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
In the present invention, unless otherwise specified, the terms "front", and "rear" are defined based on the orientation of the drawing, specifically, when the observer faces the drawing, the right side of the line of sight is defined as "front", and the left side of the line of sight is defined as "rear", "rear". In addition, in the present invention, the end of each component of the device that is closer to the operator is also referred to as the proximal end, and the end of each component of the device that is farther from the operator is referred to as the distal end.
In the present invention, the term "vascular distal protector" means a protector which, in use, is placed in a blood vessel beyond the more distal end of the surgical site, thereby trapping the dislodged thrombus mass from the surgical site from flowing further distally with the blood flow. The delivery device of the intravascular distal protector can deliver the intravascular distal protector to a designated position.
The invention provides a conveying device of a vascular distal protector, which comprises: a vascular distal protector, an outer sheath housing the vascular distal protector, and a pushing assembly for pushing or retracting the vascular distal protector. Which will be described one by one.
The vascular distal protector 2 'for intercepting blood clots falling off from the operation site may be a vascular distal protector 2' commonly used in the art, such as an umbrella protector, etc.
Preferably, in the open state, i.e. in the natural state, the vascular distal protector 2' is of elastic basket-like structure and has an opening towards the proximal end (which may also be referred to as the trailing end) of the delivery device; since the mesh of the basket-like protector is large and is not intercepted by thrombus of a smaller volume or granularity, the vascular distal protector 2' of the present invention preferably comprises, in order to intercept thrombus effectively, particularly of a smaller granularity; the metal basket body 2 and the polymer film layer coated on the metal basket body 2, wherein the polymer film layer is provided with holes 231 which are through holes and can allow blood to flow through; in order to increase the stability of the polymer film layer, the diameter of the mesh on the metal basket body is 100-5000 μm, preferably 200-2000 μm, and more preferably 300-1000 μm; 1-2000 holes 231 are uniformly distributed on each square millimeter polymer film layer, preferably, the diameter of each hole is 30-200 mu m, more preferably 60-120 mu m, and most thrombus blocks can be intercepted by the hole diameter; too few or too small holes can increase the impact force of blood flow on the vascular distal protector 2', and easily cause the vascular distal protector to shift positions; simultaneously, the blood flow is ensured to be stable, and the remote perfusion is kept.
In order to increase vascular protector 2 'and vascular wall laminating, reduce its stimulation to the blood vessel, make it can shrink into less profile, prevent to damage the vascular wall in the operation process, can play effectual support and protection to the blood vessel simultaneously, release time is more relaxed, can not tear or fish tail vascular wall, vascular distal end protector 2' is in the open state, metal basket body 2 includes: the distal end 23, the middle section 22 and the proximal end 21 are sequentially connected, see fig. 1, wherein the distal end 23 is hemispherical or semi-elliptical, the middle section 22 is cylindrical, the diameter of the cylindrical middle section 22 is equal to the diameter or the short axis of the distal end 23, the proximal end 21 is a cylinder with an inclined opening facing the proximal end (or called the rear end) of the conveying device, and the structure of the proximal end 21 is a residual cylinder formed by cutting a horizontally placed cylinder from the edge of the rear end surface obliquely forward (i.e. obliquely forward), and the residual cylinder can also be called a tangential cone; the metal basket body 2 is preferably integrally formed. Preferably, the part of the inclined opening closest to the proximal end of the delivery device is connected to the distal end of the protector wire 1, and the plane of the inclined opening forms an obtuse angle with the protector wire 1; the diameter of the middle section 22 is the same as the diameter of the proximal section. The metal basket body with the inclined opening is easy to be contained in the outer sheath tube 4, thrombus intercepted in the basket cannot deviate, the sectional area of the opening is increased, and thrombus interception is facilitated. In addition, the contact area between the vascular distal protector and the vascular wall after the vascular distal protector is opened is large, and the vascular distal protector is not easy to shift due to the impact of blood flow and thrombus.
In order to further reduce the cost and ensure the effectiveness of thrombus interception, the whole distal end part 23 of the metal basket body 2 is coated with a high polymer film layer; further preferably, a high polymer film layer is coated on the middle section 22 of the metal basket body 2; more preferably, a polymer film layer is coated at a portion of the middle section 22 that meets the distal end portion 23 of the metal basket body, and the area of the partial middle section coated with the polymer film layer accounts for 30-50% of the area of the entire middle section 22, as shown in fig. 1 as a film layer 221 coated on the partial middle section connected to the distal end portion; more preferably, the edge portion of the polymer film layer has a streamlined smooth transition region, thereby reducing irritation of the protector to the blood vessel.
The thickness of the polymer film layer is 0.1-200 μm, preferably, the average thickness of the polymer film layer coated on the inner surface of the metal basket body is 0.1-50 μm, and the average thickness of the polymer film layer coated on the outer surface of the metal basket body is 0.1-50 μm.
In the use, in order to improve the accuracy of location, be equipped with a plurality of development mark (not shown in the figure) on metal basket body 2, set up the development mark and can increase the developability under the radiation equipment condition, effectively improve the location accuracy of art person. For example, two developing marks are symmetrically arranged on the periphery of the far end of the metal basket body, two developing marks are symmetrically arranged on the periphery of the near end of the metal basket body, namely, two developing points are respectively arranged on the two sides of the head and the tail, and the developing marks can be made of Pt, au, ta or W.
The raw material of the high polymer film layer is polyurethane or polytetrafluoroethylene; the raw material of the polymer film layer is preferably polyurethane; more preferably, the polyurethane has an average molecular weight of 100000 ～ 1000000g/mol; more preferably, the polyurethane is preferably any one of a teccoflex series aliphatic polyurethane and a Pellethane2363 series 80AE aromatic polyurethane. The polymer film layer made of the material is uniform and is easy to form holes.
The metal basket body 2 is formed by weaving single or multiple metal wires made of nickel-titanium alloy; or is formed by cutting nickel-titanium alloy, medical stainless steel or cobalt-chromium alloy metal pipe by laser; or is formed by 3D printing of metal alloy powder. Wherein the nickel-titanium memory alloy skeleton has excellent elasticity and soft supporting function. The wire mesh framework used in the invention has soft texture, excellent elasticity and supporting effect, and further ensures that the framework design keeps good adherence.
The method of coating the metal basket body 2 with the polymer film layer with holes of a specific diameter may be a conventional method in the art, but is preferably the following method: dissolving a polymer film raw material in an organic solvent, adding a spherical substance (namely a pore-forming agent) with uniform diameter, which is insoluble in the organic solvent, into the organic solvent, uniformly stirring, and forming a film on the metal basket body 2 by adopting a dip coating method; after the film is formed, a solvent which can dissolve the pore-forming agent but does not dissolve the polymer film is used for repeatedly washing to form a polymer film layer with uniform holes, and a film covering method is described in detail later.
An outer sheath 4, in which an interlayer 43 is provided, the interlayer being provided along the axial direction of the outer sheath 4 and dividing the inner cavity of the outer sheath 4 into a first cavity 42 and a second cavity 41 adjacent to each other, see fig. 3 and 4; the first lumen 42 accommodates the contracted vascular distal protector 2', and the contracted vascular distal protector 2' is located at the distal end portion of the first lumen 42; the proximal material of the outer sheath 4 is preferably 304 stainless steel and the distal material is preferably nylon elastomer PEBAX. When the vascular distal protector 2' is conveyed, the second cavity 41 is used for accommodating the guide wire, and the first cavity 42 and the second cavity 41 are independent spaces, so that the guide wire and the protector cannot be embedded in the process of conveying the protector, namely, the prior common guide wire playing a guiding role is not wound with the protector, thereby bringing convenience to an operator and realizing rapid conveying and recycling of the protector.
For convenience of operation, an operating handle 5 is provided at the proximal end of the outer sheath, thereby facilitating the delivery or retrieval of the vascular distal protector 2' by the operator.
In delivering the vascular distal protector 2', the delivery device further comprises a guide wire (not shown) for guiding the outer sheath 4 carrying the protector to a predetermined position. For convenient handling of the guide wire, a side hole 411 is provided in the side wall of the outer sheath tube for forming the second lumen 41 and close to the proximal end of the outer sheath tube 4, that is, a side hole 411 is provided in the side wall of the outer sheath tube close to the proximal end of the outer sheath tube 4, the side hole 411 is communicated with the second lumen 41 and is not communicated with the first lumen 42, and in use, a part of the guide wire penetrates the second lumen 41 and the proximal end of the guide wire protrudes from the side hole 411, that is, the proximal end of the guide wire inserted into the blood vessel in advance protrudes from the distal end of the outer sheath tube 4 into the second lumen 41 and protrudes from the side hole 411.
A push assembly comprising: a push rod 3 and a protector guide wire 1 connected with the distal end of the push rod 3; the distal end of the protector guidewire 1 is connected to the proximal end of a vascular distal protector 2', see fig. 2; the push assembly is used to push the vascular distal protector 2' housed within the primary lumen 42 of the outer sheath 4 out of the distal end of the outer sheath 4.
The delivery device also comprises an extension guide wire (not shown in the figure), and the protector guide wire 1 and the pushing rod 3 can be connected through the extension guide wire, so that free switching of the length of the guide wire can be realized in operation; preferably, the extension guide wire is connected with the protector guide wire 1 in a threaded manner, and the push rod 3 is connected with the extension guide wire in a threaded manner. The design of the extension guide wire in the device can enable an operator to freely switch the length of the guide wire in operation according to the needs.
The application method of the conveying device of the vascular distal protector provided by the invention comprises the following steps: in operation, an operator firstly inserts a guide wire from the opening of a target blood vessel, inserts the proximal end of the guide wire into the second cavity 41 from the distal end of the outer sheath tube 4 of the delivery device of the invention after inserting the guide wire into a preset position, and extends out of the same side hole 411 as the second cavity 41, under the guidance of the guide wire, the outer sheath tube 4 (a developing mark can be arranged on the outer sheath tube for ensuring the position accuracy) is delivered to a specific position, and then the pushing rod is pushed forward (distally) to push the blood vessel distal protector in the first cavity 42 out of the outer sheath tube 4, so that the outer sheath tube 4 is released at the preset position, and then the outer sheath tube 4 is pulled out of the body. After the operation is finished, the vascular distal protector with the thrombus block is retracted, when the vascular distal protector is retracted, the proximal end of the protector guide wire 1 is inserted into the first cavity 42 of the outer sheath tube of the invention from the distal end of the outer sheath tube 4, and is pulled out from the proximal end port of the outer sheath tube, and the protector guide wire is pulled to the proximal end continuously, so that the vascular distal protector is contained in the first cavity 42, and then the operating handle 5 is held, and the vascular distal protector is completely withdrawn from a human body.
The following describes in detail the method for coating the metal basket body 2 with the polymer film layer with holes of specific diameter, which specifically comprises the following steps:
step one, dissolving a raw material of a high polymer film in an organic solvent and adding a pore-forming agent to form a pre-coating liquid; preferably, the mass ratio of the pore-forming agent to the raw materials of the polymer film is 1:2-20 (such as 1:3, 1:4, 1:5, 1:7, 1:10, 1:12, 1:14, 1:15, 1:17, 1:19); more preferably, the pore-forming agent is insoluble in the organic solvent; further preferably, the particle size of the pore former is 30-200 μm (e.g. 40-180 μm, 40-150 μm, 40-120 μm, 50 μm, 60 μm, 70 μm, 80 μm, 90 μm, 160 μm), preferably 60-120 μm;
step two, degassing the precoating liquid to obtain a coating liquid;
step three, dip-coating the coating liquid on the metal basket body 2 by adopting a dip-coating method, carrying out air-drying treatment on the metal basket body 2 after dip-coating each time, and carrying out dip-coating and air-drying treatment for multiple times to obtain a metal basket body with a coating;
step four, flushing the metal net blue body with the coating for multiple times by adopting a reagent until the pore-forming agent is completely washed to form holes, and then drying to obtain the elastic protective net basket; preferably, the agent is capable of dissolving the pore-forming agent but not the polymeric film; preferably, the holes are through holes.
Further, the method further comprises: and (3) performing laser engraving modification on the edge part of the polymer film to form a streamline smooth transition region.
Further, the mass volume ratio of the raw materials of the polymer film to the organic solvent is 0.001-0.1 g/mL (such as 0.002g/mL, 0.005g/mL, 0.01g/mL, 0.03g/mL, 0.05g/mL, 0.07g/mL, 0.09 g/mL); preferably, the organic solvent is one or more of dichloromethane, chloroform, methanol, ethanol, acetone and tetrahydrofuran.
The mass volume ratio of the raw materials of the polymer film to the organic solvent is too large, so that the concentration of the polymer film is too large, the concentration of the pore-forming agent in the organic solvent is correspondingly increased, the coating liquid is not easy to dip-coat on the metal basket body, the uniformity and the thickness of the polymer film are also easy to cause, the phenomenon of hole accumulation can occur, namely, holes cannot be uniformly distributed on the polymer film, and false holes can be caused. The too small mass-volume ratio can cause the too small concentration of the polymer film and the pore-forming agent, so that the coating liquid is not easy to cover the metal basket body, and the uniformity of the polymer film and the uniformity of hole distribution can be poor. Compared with the first method, the second method has simpler process and more convenient operation, and can greatly improve the efficiency.
Further, degassing treatment is carried out by adopting ultrasonic waves; preferably, the temperature of the degassing treatment is 0-40deg.C (such as 5deg.C, 10deg.C, 15deg.C, 20deg.C, 25deg.C, 30deg.C, 35deg.C) and the time is 2-10 h (such as 4h, 5h, 6h, 7h, 8h, 9 h); more preferably, the frequency of the ultrasonic wave is 50-130 KHz (such as 60KHz, 70KHz, 80KHz, 90KHz, 100KHz, 110KHz, 120 KHz); preferably, the coating liquid is dip-coated on the metal basket body 2 under nitrogen or argon atmosphere; more preferably, in the third step, the air-drying treatment is performed in an atmosphere of nitrogen or argon at a temperature of 25-35 ℃ (such as 26 ℃, 27 ℃, 28 ℃, 30 ℃, 32 ℃, 34 ℃) for a time of 5-30 min (such as 8min, 10min, 15min, 20min, 25min, 28 min); more preferably, in step four, drying is performed in a vacuum drying oven at a temperature of 25 to 60 ℃ (e.g. 26 ℃, 30 ℃, 35 ℃, 40 ℃, 45 ℃, 50 ℃, 55 ℃) for a time of 1 to 12 hours (e.g. 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours).
Preferably, the pore-forming agent is water-soluble ammonium salt or water-soluble polymer material; the water-soluble ammonium salt is preferably ammonium carbonate, ammonium bicarbonate, ammonium chloride, ammonium sulfate or ammonium bisulfate; the water-soluble polymer material is preferably polyethylene glycol or polyethylene oxide. The reagent is preferably purified water.
In the second film coating method, the ultrasonic wave is adopted for degassing treatment, so that oxygen and other gases in the pre-coating liquid can be removed, air holes in the pre-coating liquid can be reduced, generation of air holes in a polymer film can be avoided, oxidization of net wires in a metal net basket can be avoided, and polymer film raw materials and pore formers in the pre-coating liquid can be uniformly distributed in an organic solvent, so that the uniform anaerobic pre-coating liquid can be prepared, a film with uniform hole distribution can be formed, and the holes can be ensured to be basically penetrating through holes.
In order to describe the film coating method in more detail, the present invention enumerates 6 examples.
Example 1
The diameter of the mesh on the metal basket body is 700 μm.
(1) Dissolving Pellethane2363 series 80AE aromatic polyurethane in tetrahydrofuran, adding 60 mu m ammonium carbonate pore-forming agent, and uniformly stirring to form a pre-coating liquid; the mass volume ratio of the Pellethane2363 series 80AE aromatic polyurethane to the tetrahydrofuran is 0.02g/mL; the mass ratio of the ammonium carbonate to the Pellethane2363 series 80AE aromatic polyurethane is 1:5;
(2) Degassing the pre-coating liquid in the step (1) under the nitrogen condition by ultrasonic waves with the frequency of 80KHz, wherein the temperature of the degassing treatment is 25 ℃ and the time is 5 hours, so as to obtain the coating liquid;
(3) Dip-coating the coating liquid in the step (2) on the whole distal end part of the metal basket body by adopting a dip-coating method under the nitrogen condition, airing the metal basket body for 10 minutes at 25 ℃ under the nitrogen condition after dip-coating once, and airing the metal basket body for multiple times to obtain a metal basket body with a coating;
(4) And (3) washing the metal basket body with the coating in the step (3) for multiple times by adopting purified water until the ammonium carbonate pore-forming agent is completely washed away to form a through hole, and then drying the through hole in a vacuum drying oven at 40 ℃ for 5 hours to obtain the elastic protection basket. Preferably, the edge of the polymer film can be subjected to laser engraving decoration to form a streamline smooth transition zone so as to reduce the irritation of the protector to the blood vessel.
In the embodiment, the thickness of the polymer film layer is uniform, and the holes are uniformly distributed on the polymer film layer; the thickness of the polymer film layer is 60 mu m, the average thickness of the polymer film layer coated on the inner surface of the metal basket body is 30 mu m, the average thickness of the polymer film layer coated on the outer surface of the metal basket body is 30 mu m, and the diameter of the holes on the polymer film is 60 mu m.
In being arranged in cerebral vein interventional molding, the distal vascular protector that adopts the elasticity protection basket of this embodiment to obtain can intercept more than 0.06mm thrombus, guarantees that broken thrombus can not cause drift or re-embolism, and blood flow velocity is suitable and stable, excellent in use effect.
Example 2
The diameter of the mesh on the metal basket body is 800 μm.
(1) Dissolving Pellethane2363 series 80AE aromatic polyurethane in chloroform, adding 120 mu m ammonium chloride pore-forming agent, and stirring uniformly to form pre-coating liquid; the mass volume ratio of the Pellethane2363 series 80AE aromatic polyurethane to the chloroform is 0.001g/mL; the mass ratio of the ammonium chloride to the Pellethane2363 series 80AE aromatic polyurethane is 1:10;
(2) Degassing the pre-coating liquid in the step (1) under the nitrogen condition by ultrasonic waves with the frequency of 100KHz, wherein the temperature of the degassing treatment is 30 ℃ and the time is 8 hours, so as to obtain the coating liquid;
(3) Dip-coating the coating liquid in the step (2) on the whole distal end part of the metal basket body by adopting a dip-coating method under the nitrogen condition, airing the metal basket body for 15 minutes at 30 ℃ under the nitrogen condition once for dip-coating, and airing the metal basket body for multiple times to obtain a metal basket body with a coating;
(4) And (3) washing the metal basket body with the coating in the step (3) for multiple times by adopting purified water until the ammonium chloride pore-forming agent is completely washed away to form a through hole, and then drying the through hole in a vacuum drying oven at 40 ℃ for 6 hours to obtain the elastic protection basket. Preferably, the edge of the polymer film can be subjected to laser engraving decoration to form a streamline smooth transition zone so as to reduce the irritation of the protector to the blood vessel.
In the embodiment, the thickness of the polymer film layer is uniform, and the holes are uniformly distributed on the polymer film layer; the thickness of the polymer film layer is 110 mu m, the average thickness of the polymer film layer coated on the inner surface of the metal basket body is 55 mu m, the average thickness of the polymer film layer coated on the outer surface of the metal basket body is 55 mu m, and the diameter of the holes on the polymer film is 120 mu m.
In being arranged in cerebral vein interventional molding, the distal vascular protector that adopts the elasticity protection basket of this embodiment to obtain can intercept more than 0.12mm thrombus, guarantees that broken thrombus can not cause drift or re-embolism, and blood flow velocity is suitable and stable, excellent in use effect.
Example 3
The diameter of the mesh on the metal basket body is 900 μm.
(1) Dissolving Pellethane2363 series 80AE aromatic polyurethane in methanol, adding 70 mu m polyethylene glycol pore-forming agent, and stirring uniformly to form a pre-coating liquid; the mass volume ratio of the Pellethane2363 series 80AE aromatic polyurethane to the methanol is 0.08g/mL; the mass ratio of polyethylene glycol to Pellethane2363 series 80AE aromatic polyurethane is 1:20;
(2) Degassing the pre-coating liquid in the step (1) under the nitrogen condition by ultrasonic waves with the frequency of 120KHz, wherein the temperature of the degassing treatment is 25 ℃ and the time is 7 hours, so as to obtain the coating liquid;
(3) Dip-coating the coating liquid in the step (2) on the whole distal end part of the metal basket body by adopting a dip-coating method under the nitrogen condition, airing the metal basket body for 15 minutes at 30 ℃ under the nitrogen condition once for dip-coating, and airing the metal basket body for multiple times to obtain a metal basket body with a coating;
(4) And (3) washing the metal basket body with the coating in the step (3) for multiple times by adopting purified water until the polyethylene glycol pore-forming agent is completely washed away to form through holes, and then drying the through holes in a vacuum drying oven at 45 ℃ for 5 hours to obtain the elastic protection basket. Preferably, the edge of the polymer film can be subjected to laser engraving decoration to form a streamline smooth transition zone so as to reduce the irritation of the protector to the blood vessel.
In the embodiment, the thickness of the polymer film layer is uniform, and the holes are uniformly distributed on the polymer film layer; the thickness of the polymer film layer is 40 mu m, the average thickness of the polymer film layer coated on the inner surface of the metal basket body is 20 mu m, the average thickness of the polymer film layer coated on the outer surface of the metal basket body is 20 mu m, and the diameter of the holes on the polymer film is 70 mu m.
In being arranged in cerebral vein interventional molding, the distal vascular protector that adopts the elasticity protection basket of this embodiment to obtain can intercept more than 0.07mm thrombus, guarantees that broken thrombus can not cause drift or re-embolism, and blood flow velocity is suitable and stable, excellent in use effect.
Example 4
The diameter of the mesh on the metal basket body is 300 μm.
(1) Dissolving Pellethane2363 series 80AE aromatic polyurethane in tetrahydrofuran, adding a polyethylene oxide pore-forming agent with the diameter of 20 mu m, and uniformly stirring to form a pre-coating liquid; the mass volume ratio of the Pellethane2363 series 80AE aromatic polyurethane to the tetrahydrofuran is 0.01g/mL; the mass ratio of polyethylene oxide to the Pellethane2363 series 80AE aromatic polyurethane is 1:2;
(2) Degassing the pre-coating liquid in the step (1) under the nitrogen condition by ultrasonic waves with the frequency of 100KHz, wherein the temperature of the degassing treatment is 25 ℃ and the time is 5 hours, so as to obtain the coating liquid;
(3) Dip-coating the coating liquid in the step (2) on the whole distal end part of the metal basket body by adopting a dip-coating method under the nitrogen condition, airing the metal basket body for 10 minutes at 25 ℃ under the nitrogen condition after dip-coating once, and airing the metal basket body for multiple times to obtain a metal basket body with a coating;
(4) And (3) washing the metal basket body with the coating in the step (3) for multiple times by adopting purified water until the polyethylene oxide pore-forming agent is completely washed away to form a through hole, and then drying the through hole in a vacuum drying oven at 40 ℃ for 5 hours to obtain the elastic protection basket. Preferably, the edge of the polymer film can be subjected to laser engraving decoration to form a streamline smooth transition zone so as to reduce the irritation of the protector to the blood vessel.
In the embodiment, the thickness of the polymer film layer is uniform, and the holes are uniformly distributed on the polymer film layer; the thickness of the polymer film layer is 20 mu m, the average thickness of the polymer film layer coated on the inner surface of the metal basket body is 10 mu m, the average thickness of the polymer film layer coated on the outer surface of the metal basket body is 10 mu m, and the diameter of the holes on the polymer film is 20 mu m.
In being used for cerebral vein interventional molding, the distal vascular protector that adopts the elasticity protection basket of this embodiment to obtain can intercept more than 0.05mm thrombus, guarantees that broken thrombus can not cause drift or re-embolism, and blood flow velocity is stable but the undersize, and the result of use is general.
Example 5
The diameter of the mesh on the metal basket body is 1000 μm.
(1) Dissolving Pellethane2363 series 80AE aromatic polyurethane in ethanol, adding 100 mu m ammonium sulfate pore-forming agent, and uniformly stirring to form a pre-coating liquid; the mass volume ratio of the Pellethane2363 series 80AE aromatic polyurethane to the ethanol is 0.15g/mL; the mass ratio of the ammonium sulfate to the Pellethane2363 series 80AE aromatic polyurethane is 1:1;
(2) Degassing the pre-coating liquid in the step (1) under the nitrogen condition by ultrasonic waves with the frequency of 80KHz, wherein the temperature of the degassing treatment is 25 ℃ and the time is 5 hours, so as to obtain the coating liquid;
(3) Dip-coating the coating liquid in the step (2) on the whole distal end part of the metal basket body by adopting a dip-coating method under the nitrogen condition, airing the metal basket body for 10 minutes at 35 ℃ under the nitrogen condition after dip-coating once, and airing the metal basket body for multiple times to obtain a metal basket body with a coating;
(4) And (3) washing the metal basket body with the coating in the step (3) for multiple times by adopting purified water until the ammonium sulfate pore-forming agent is completely washed away to form holes, and then drying the holes in a vacuum drying oven at 50 ℃ for 5 hours to obtain the elastic protection basket. Preferably, the edge of the polymer film can be subjected to laser engraving decoration to form a streamline smooth transition zone so as to reduce the irritation of the protector to the blood vessel.
In the embodiment, the concentration of the Pellethane2363 series 80AE aromatic polyurethane and the ammonium sulfate in the coating liquid is too high, so that the thickness of the polymer film layer is uneven, and the phenomenon of hole part aggregation occurs, namely holes are not uniformly distributed on the polymer film layer; the thickness of the polymer film layer is 80 mu m, the average thickness of the polymer film layer coated on the inner surface of the metal basket body is 40 mu m, the average thickness of the polymer film layer coated on the outer surface of the metal basket body is 40 mu m, and the holes on the polymer film are provided with partial non-penetrating holes, namely false holes, so that the blood flow is unsmooth, the far-end blood flow is influenced, and certain side effects are generated on patients.
Example 6
The diameter of the mesh on the metal basket body is 1200 μm.
(1) Dissolving Pellethane2363 series 80AE aromatic polyurethane in ethanol, adding 150 mu m ammonium bisulfate pore-forming agent, and stirring uniformly to form a pre-coating liquid; the mass volume ratio of the Pellethane2363 series 80AE aromatic polyurethane to the ethanol is 0.05g/mL; the mass ratio of the ammonium sulfate to the Pellethane2363 series 80AE aromatic polyurethane is 1:7;
(2) Dip-coating the precoating liquid in the step (1) on the whole distal end part of the metal basket body by adopting a dip-coating method under the nitrogen condition, airing the metal basket body for 10 minutes at 35 ℃ under the nitrogen condition after dip-coating once, and airing the metal basket body for multiple times to obtain a coated metal basket body;
(3) And (3) washing the metal basket body with the coating in the step (2) for multiple times by adopting purified water until the ammonium bisulfate pore-forming agent is completely washed away to form honeycomb holes, and then drying the honeycomb holes in a vacuum drying oven at 50 ℃ for 5 hours to obtain the elastic protection basket. Preferably, the edge of the polymer film can be subjected to laser engraving decoration to form a streamline smooth transition zone so as to reduce the irritation of the protector to the blood vessel.
In this embodiment, the pre-coating solution is not subjected to ultrasonic degassing treatment, so that the thickness uniformity of the polymer film layer is poor, i.e. the holes are not uniformly distributed on the polymer film layer; the thickness of the polymer film layer is 150 mu m, the average thickness of the polymer film layer coated on the inner surface of the metal basket body is 75 mu m, the average thickness of the polymer film layer coated on the outer surface of the metal basket body is 75 mu m, and the holes on the polymer film are partially non-through holes, namely false holes appear, so that the blood flow is unsmooth, the far-end blood flow is influenced, and certain side effects are generated on patients.